Crucial Steps to Follow in Medical Device Development

Alex D'Souza, Medical Tech Outlook | Wednesday, February 09, 2022

A medical device program's success ultimately depends on ensuring that all critical steps are followed to establish the framework for a future successful medical program.

Fremont, CA: When a program is accepted, the process of ensuring effective assembly for medical device development projects begins. When companies outsource their medical device development to a contract manufacturer, they must make sure to follow a few key procedures to ensure the program's success once it reaches the full-scale assembly stage.

Steps to follow for Medical Device Development

Readiness review

When a contract manufacturer accepts an order to create new medical equipment, the first thing they do is conduct a readiness check. This examination is a thorough examination of the design and requirements provided by the client to the contract manufacturer. The goal of this evaluation is to see if the customer's input will result in a product that is both manufacturable and capable of meeting the specified design and function.

Developing manufacturing process

The contract manufacturer's engineering and manufacturing teams should begin developing the methods needed to manufacture and build the medical device as the next phase in the development process. During this step, managers from each department collaborate to develop the full production process so that component parts may be completed at the same time and the prototype can be finished on schedule.

Manufacturing medical device parts

Following the start of process development, the component parts are released to the manufacturing floor. A cross-functional initiative between quality control and floor employees is developed throughout this step to inspect all of the component parts for a medical device development program.

Final testing

Once all of the elements are in place, the medical device prototype or alpha/beta models can be constructed, tested, and double-checked to verify they fulfill the customer's requirements. Both the internal and customer engineering teams create these tests to ensure that they meet the quality and functional criteria.

Release medical product for production

The development phase of the medical device is now complete, and the new medical product is ready to be put into production. Supervisors from both the NPI and Assembly divisions will meet internally during this process to guarantee a smooth transition. When establishing floor plans for the region, assembly floor supervisors will meet with their team members to ensure that a seamless, flowing procedure is established and approved by the entire team.